N-glycan Analysis in Molecular Medicine: Innovator and Biosimilar Protein Therapeutics

Title:N-glycan Analysis in Molecular Medicine: Innovator and Biosimilar Protein Therapeutics

Volume: 20 Issue: 10

Author(s): Beata Borza, Laszlo Hajba*Andras Guttman

Affiliation:

• Horvath Csaba Memorial Institute of Bioanalytical Research, Research Institute of Biomolecular and Chemical Engineering, University of Pannonia,Hungary

Keywords: Biosimilar, biosimilarity, biotherapeutics, glycosylation, antibody, analysis, capillary electrophoresis, high performance liquid chromatography.

Abstract: The market segment of new biological drugs (monoclonal antibodies, fusion proteins, antibody-drug conjugates, and new modality protein therapeutics) is rapidly growing, especially after the patent expiration of the original biologics, initiating the emergence of biosimilars. N-glycosylation of therapeutic proteins has high importance on their stability, safety, immunogenicity, efficacy, and serum half-life. Therefore, Nglycosylation is considered to be one of the critical quality attributes. Consequently, it should be rigorously monitored during the development, manufacturing, and release of glycoprotein biologicals. In this review, first, the regulatory considerations for biosimilars are shortly summarized, followed by conferring the analytical techniques needed for monitoring and characterization of the N-glycosylation of biological drugs. Particular respect is paid to liquid phase separation techniques with high sensitivity and highresolution detection methods, including laser-induced fluorescence and mass spectrometry.

Cite this article as:

Borza Beata , Hajba Laszlo *, Guttman Andras , N-glycan Analysis in Molecular Medicine: Innovator and Biosimilar Protein Therapeutics, Current Molecular Medicine 2020; 20 (10) . https://dx.doi.org/10.2174/1566524020999201203212352